Senior Clinical Research Associate

Senior Clinical Research Associate - Temporary contract - FSP

Overview

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Flexible
• Organized
• Problem-solver
• Self-starter

About This Role

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

Key Accountabilities:

Oversight of Monitoring Responsibilities and Study Conduct

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
• Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
• Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines

Skills

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
• Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Global clinical trial experience
• Must be fluent in English
• Significant travel across whole Turkey
• Valid driver’s license and passport required

Knowledge and Experience:

• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
• Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)
• Demonstrated ability to support sponsor regulatory interactions/inspections
• Demonstrated knowledge of the processes around protocol design and feasibility assessment
• Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
• Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation

Education

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

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• Potential Career Path

• Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

• APEX CRA

• CRA I

• CRA II

• Senior CRA

• Project Management

• Subject Matter Expert

• People Management

• Employee Insights

• Nick on a day in the life of a CRA

• Nick Burger | Senior Clinical Research Associate

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• Liliana on CRA tasks and our recognition program

• Liliana Belmares Flores | CRA Line Manager

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• Marlayna on why Parexel is a great place for CRAs

• Marlayna Fitts | CRA Line Manager

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• TEAM IMPRESSIONS

• Why Clinical Research Associates work at Parexel

• Patient-focused in everything we do

• We push the boundaries of what is possible to create clinical trials that are inclusive, innovative, and patient-focused

• Supportive and inclusive environment

• We foster collaboration, teamwork, respect, and inclusivity, to work together to achieve common goals.

• Career growth and development

• We develop your skills through training, mentorship, and career advancement programs.

• Flexible work arrangements

• We focus on outputs and results, not where and when you work.

• Diverse therapeutic areas and project exposure

• We continuously learn from a broad exposure from early to late phase clinical trials and our cross-functional global teams.

• Advanced Technology

• We recognize the importance of first-time quality to bring treatments to patients faster.

• Learn About Our Culture

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• Careers in Oncology

• Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

• Careers in Rare Diseases

• In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

• Emerging Talent Opportunities

• Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level cli